Clinical trial · Observational
Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts
Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer
NCT03735550CI-TRIAL-00036236unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contact thermographic breast examination device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A age: 18-49
- description
- Women aged 18-49 who had breast ultrasound performed with a result of BI-RADS 4b, 4c or 5. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to breast ultrasound. The planned number of participants in the group: n=700 people.
- interventionNames
- Device: Contact thermographic breast examination device
- label
- Group B age: 50 and above
- description
- Women aged 50 and above who had mammography and/or breast ultrasound performed (both examinations are obligatory, i.e. if the subject was recruited based on mammography, then ultrasound must be performed and vice-versa). Women were recruited if they had a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or BI-RADS 4a, 4b, 4c or 5 on ultrasound. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to the aforementioned techniques. The planned number of participants in the group: n=2100 people.
- interventionNames
- Device: Contact thermographic breast examination device
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- a woman aged 18 or above (without any upper age limit) who gives informed consent to the participation in the study by signing the Informed Consent Form and meets one of the below requirements may take part in the study: 1. For women aged 18-49: ultrasound imaging of breasts was performed; category of the final assessment of the study according to the BI-RADS scale 4b, 4c or 5. 2. For women aged 50 or above (in the B group, a mammography examination in the final assessment category according to the BI-RADS scale 4, 4a, 4b, 4c or 5; or the breast ultrasound in the final assessment category according to the BI-RADS scale 4a, 4b, 4c or 5 (but both examinations are obligatory); in the C2 group, mammography or breast ultrasound in the final category of the examination assessment according to the BI-RADS scale 1, 2 (but both examinations are obligatory). - Exclusion Criteria: 1. Performed invasive diagnostics of changes in breasts (treatment performed less than 12 months before inclusion into the study) - relates to a core- needle and mammotome biopsy (also a fine-needle biopsy performed up to 4 weeks before inclusion to the study). 2. A breast surgery within 12 months before inclusion into the study (including cosmetic surgeries, i.e. aesthetic implants, fat-graft transfer and hyaluronic acid injection into breasts. 3. A visible, considerable breasts asymmetry that makes the examination with an equal number of matrix applications on both breasts impossible. 4. A visible considerable breast deformation including appearance of scarring on the breast skin which makes adjustment of the entire matrix surface to the breast gland impossible. 5. Previous or ongoing anti-tumour treatment due to the breast cancer. 6. Symptomatic acute or chronic breast inflammation, with visible features of inflammation: pain, increased temperature, skin redness, swelling, breast abscesses, breast vessels thrombosis. 7. Injury to the breasts with visible clinical properties of extravasation. 8. A patient is suffering from an active infection with the body temperature equal to or more than 37.5°C. 9. Pregnancy and lactation (pregnancy must be ruled out based on the last period date (\< 30 days), or using effective contraception - with regard to women from group A, in case of any doubts performance of the stripe pregnancy test). 10. Alcohol consumption on the day of the visit at the doctor's. 11. Intensive physical effort up to 30 minutes before thermographic examination. 12. Bath/shower (approximately 2 hours before thermographic examination). 13. Using sauna/ steam bath on the day of examination, before thermographic examination. 14. Cosmetic and beauty treatments before examination: peeling within the neckline and breasts, hair removal within armpits, application of cosmetics on the breast skin (approximately 2 hours before thermographic examination). 15. A direct stay close to the heat or cold sources such as heaters or air conditioners 30 minutes before thermographic examination.
References
Publications (0)
Data not yet available
No reference posted for this study.